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Company Name : BioPhase
Location : San Diego, CA 92121
Position : Clinical Trial Specialist (CTS)
Job Description : Clinical Trial SpecialistDepartment: Clinical PharmacologyPrimary responsibility will be the review of Trial Master Files for completed and ongoing Clinical Pharmacology studies, and ensuring timely and accurate study-related communication to Clinical personnel.We are seeking a highly motivated individual to join us as a Clinical Trial Specialist (CTS) within the Clinical Pharmacology Operation Team, reporting into a Director of Clinical Science, Clinical Pharmacology. Primary responsibility includes quarterly and final review of Trial Master Files (TMFs) for ongoing Clinical Pharmacology studies conducted with healthy volunteers and specific sub-populations (i.e. renal and hepatic impairment). Each TMF is managed by a CRO until study close-out. TMF review includes review of all folders and files/documents for completeness and accuracy, and regular communication with CRO counterpart for resolution of discrepancies and missing/mis-filed documents. Reviews are documented and filed. Other study related tasks may be assigned as needed. Including -Ensures timely and accurate study-related communication to clinical personnel (i.e., internal and external study teams, consultants and investigative site personnel): prepares and disseminates clinical trial correspondence, newsletters, etc. (working with project clinician), and assists with creating study-specific manuals, tools, and templatesParticipate in selection and management/oversight of external vendors and develop vendor specifications; review vendor reports, budgets, and metrics; acts as liaison between vendors and sites (e.g., assists site with laboratory sample queries)Coordinate specified clinical trial meetings (e.g., investigator meetings, Study team meetings, CRA and CRO meetings) by arranging logistics, preparing necessary materials and recording and distributing minutesSet-up, track, and maintain audit-ready clinical trial documentation and study status in clinical trial management system: manage and track regulatory/IRB/EC documentation, IND Safety Letter distribution, Confidentiality Disclosure Agreements, and other clinical trial documents; generate, review and distribute reports; assist with quality assurance audits and resolution of audit findingsParticipate in study design and execution by contributing operational experience and expertise: provide input into protocol, ICF, CRF design, monitoring conventions, edit checks and vendor specifications; assists with study or site feasibility process; participate in site monitoring visits, as appropriate; post and maintain study-related information on external websites when applicableQualifications: Bachelors or equivalent in a scientific or health care field preferred.Minimum of 2-7 years of relevant experience required, including CTA duties, and experience reviewing TMFsExperience in clinical pharmacology clinical trials preferred.Clinical operations experience at a small or mid-size company.Knowledge of ICH/GCP guidelines, regulatory requirements and clinical trial operations.Excellent verbal and written communication skills.Please feel free to visit biophaseinc.com for additional Clinical Research opportunities.Job Type: Full-timePay: $75,000.00 – $105,000.00 per yearBenefits:401(k)401(k) matchingDental insuranceEmployee assistance programEmployee discountFlexible scheduleFlexible spending accountHealth insuranceHealth savings accountLife insurancePaid time offParental leaveProfessional development assistanceReferral programRelocation assistanceRetirement planTuition reimbursementVision insuranceSchedule:8 hour shiftMonday to FridaySupplemental Pay:Bonus paySigning bonusEducation:High school or equivalent (Preferred)Work Location: Multiple Locations
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